The purpose of this study is to find out how balloon kyphoplasty (surgical repair of the patient's fracture using balloons and bone cement) compares to non-surgical treatment in reducing vertebral compression fractures while providing pain relief and improved function and quality of life.
This is a prospective single center study designed to compare balloon kyphoplasty to non-surgical management (NSM) in the treatment of mildly painful, acute vertebral body compression fractures in multiple myeloma patients. Because of the pilot nature and the small sample size of the study, patient randomization will NOT be stratified. Patients with mildly symptomatic vertebral compression fractures (VCFs) will undergo a 1:1 randomization either balloon kyphoplasty or non surgical management. Randomization assignments will be generated by computer and investigator notified once the patient enrolled. The observational arm will be compared to each of the other two arms; control and intervention arm using the same outcome variables and statistical methods.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Two small metal tubes will be inserted through the skin into the collapsed bone. Inflatable bone tamps (balloon catheters) will be inserted through each of these two tubes into the bone. The balloons will be inflated with a liquid that can be seen on xrays (contrast) to return the bone toward its natural shape and create a cavity. The balloons will then be deflated and removed. The cavity in the bone will be filled with bone cement to stabilize the broken backbone.
Non-surgical treatment means the institution of therapies other than cancer chemotherapy and surgical treatment aimed at alleviation of back pain and restoration of decreased function associated with the patient's VCF(s).
Time to Vertebral Event
Time to vertebral event (composite end point of pain progression, hospitalization for pain, and rescue vertebral augmentation or surgery or radiation therapy as related to an index fracture)
Time frame: Average of 12 months
Time to Pain Progression
Time to pain progression defined as the time to the development of pain severity rated greater than 4 on the visual analog scale (VAS) as related to an index fracture
Time frame: Average of 12 months
Rate of Vertebral Events
Rate of vertebral events in patients with asymptomatic vertebral compression fracture at 12 months
Time frame: 12 months
Rate of Hospitalization
Rate of hospitalization for pain control in patients with asymptomatic or mildly symptomatic vertebral compression fracture at 12 months
Time frame: 12 months
Complications of Procedure
Complications of vertebral augmentation
Time frame: Average of 12 months
Quality of Life Questionnaire Results
Quality of life as assessed by the Functional Assessment of Cancer Treatment - General (FACT-G) questionnaire in all enrolled patients and Roland Morris disability questionnaire for spine disability
Time frame: Average of 12 months
Changes in Pulmonary Function
Changes in pulmonary function testing in patients with thoracic spine vertebral compression fracture
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Time frame: Average of 12 months
Change in Kyphosis
Change in kyphosis as measured by the Cobb method and change in vertebral collapse by the method of Genant
Time frame: Average of 12 months
Prognostic Ability of Bone Biomarkers
Prognostic ability of bone biomarkers for the prediction of vertebral events
Time frame: Average of 12 months